The EMDR Recent Birth Trauma Protocol: a pilot randomised clinical trial after traumatic childbirth.

Objective: This pilot study investigated the effectiveness of brief EMDR intervention as compared to treatment-as-usual (TAU) in women with post-partum PTSD symptoms.Design: A pilot randomised controlled trial was conducted to evaluate possible differences between one EMDR session (n = 19) and one TAU session (n = 18) delivered in a maternity ward in the aftermath of childbirth.Main Outcome Measures: The primary outcome measure was the rate of remission of post-partum post-traumatic stress symptoms (i.e. IES-R score <23) in both groups at 6-weeks (T1) and 12-weeks' post-partum (T2). Secondary outcome measures were mother-to-infant bonding, post-partum depressive symptoms, the presence of flashbacks and level of distress.Results: Most of the women improved their post-partum post-traumatic stress symptoms after only one treatment session. EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU; p = .020). Moreover, women treated with EMDR experienced less flashbacks and distress as compared to TAU. No significant difference was found between treatments on mother-to-infant bonding and post-partum depressive symptoms.Conclusions: These findings, although preliminary, suggest that a brief EMDR intervention could be a viable and promising tool in the early treatment of post-traumatic stress related to traumatic childbirth.

Influence of relative humidity during coating on polymer deposition and film formation.

The influence of relative humidity in the pan during coating on polymer deposition and film formation was investigated. Four tablet substrates, differing in hydrophobicity, porosity, and surface roughness, were prepared and coated with Eudragit(®) RS/RL 30 D (8:2 ratio). The spray rate and atomization air pressure were varied to create two distinct micro-environmental conditions in the coating pan. PyroButton data logging devices placed directly in the pan were found to more accurately reflect the relative humidity to which tablets were exposed in comparison to measurements taken at the exhaust. Polymer deposition was shown to be influenced by the properties of the substrate, rather than the processing conditions used during coating, with higher polymer weight gains observed for the more porous tablets. Differences in the film-tablet interface and in the release performance of the coated products, however, were attributed to both the relative humidity in the pan and tablet porosity. Overall, this study demonstrated that a more humid coating process (86% vs 67%) promoted surface dissolution and physical mixing of the tablet ingredients with the forming film and the extent of this phenomenon was dependent on the tablet porosity.

Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules.

In a previous study, hydroxypropyl cellulose (HPC)-based capsular shells prepared by injection molding and intended for pulsatile release were successfully coated with 10mg/cm(2) Eudragit® L film. The suitability of HPC capsules for the development of a colon delivery platform based on a time dependent approach was demonstrated. In the present work, data logging devices (PyroButton®) were used to monitor the microenvironmental conditions, i.e. temperature (T) and relative humidity (RH), during coating processes performed under different spray rates (1.2, 2.5 and 5.5g/min). As HPC-based capsules present special features, a preliminary study was conducted on commercially available gelatin capsules for comparison purposes. By means of PyroButton data-loggers it was possible to acquire information about the impact of the effective T and RH conditions experienced by HPC substrates during the process on the technological properties and release performance of the coated systems. The use of increasing spray rates seemed to promote a tendency of the HPC shells to slightly swell at the beginning of the spraying process; moreover, capsules coated under spray rates of 1.2 and 2.5g/min showed the desired release performance, i.e. ability to withstand the acidic media followed by the pulsatile release expected for uncoated capsules. Preliminary stability studies seemed to show that coating conditions might also influence the release performance of the system upon storage.

Injection-molded capsular device for oral pulsatile release: development of a novel mold.

The development of a purposely devised mold and a newly set up injection molding (IM) manufacturing process was undertaken to prepare swellable/erodible hydroxypropyl cellulose-based capsular containers. When orally administered, such devices would be intended to achieve pulsatile and/or colonic time-dependent delivery of drugs. An in-depth evaluation of thermal, rheological, and mechanical characteristics of melt formulations/molded items made of the selected polymer (Klucel® LF) with increasing amounts of plasticizer (polyethylene glycol 1500, 5%-15% by weight) was preliminarily carried out. On the basis of the results obtained, a new mold was designed that allowed, through an automatic manufacturing cycle of 5 s duration, matching cap and body items to be prepared. These were subsequently filled and coupled to give a closed device of constant 600 µm thickness. As compared with previous IM systems having the same composition, such capsules showed improved closure mechanism, technological properties, especially in terms of reproducibility of the shell thickness, and release performance. Moreover, the ability of the capsular container to impart a constant lag phase before the liberation of the contents was demonstrated irrespective of the conveyed formulation.